FDA device listing
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
FDA device listing 1284833985 · Nittobo Medical Co., Ltd.
Key facts
| Owner/operator | Nittobo Medical Co., Ltd. |
|---|---|
| Owner/operator number | 9028746 |
| Premarket submissions | K983070 |
| Product codes | CGS |
| Device names | CGS - Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1215 |
| Review panels | Clinical Chemistry |
| Registered establishments | NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER |
| Establishment registrations | 1000403749 |
| FEI numbers | 1000403749 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database